The following data is part of a premarket notification filed by Physiq, Inc with the FDA for Physiq Heart Rhythm And Respiration Module.
| Device ID | K193415 |
| 510k Number | K193415 |
| Device Name: | PhysIQ Heart Rhythm And Respiration Module |
| Classification | Electrocardiograph |
| Applicant | physIQ, Inc 300 E. 5th Avenue, Suite 105 Naperville, IL 60563 |
| Contact | George Allen Hides |
| Correspondent | George Allen Hides physIQ, Inc 300 E. 5th Avenue, Suite 105 Naperville, IL 60563 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-09 |
| Decision Date | 2020-06-11 |